Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-29 @ 4:45 PM
Study NCT ID:
NCT01198600
Status:
COMPLETED
Last Update Posted:
2012-08-29
First Post:
2010-09-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ocular Comfort and the "Aging" Lens (ERBIUM)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-241-7629', 'title': 'R. Alan Landers, O.D., M.S., F.A.A.O.', 'organization': 'Alcon Research'}, 'certainAgreement': {'otherDetails': "For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The current study design and sample size was not able to uncover clinically meaningful differences between survivors and strugglers. There is considerable individual variation in lens performance with age, which requires further investigation.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the duration of the study: 8-JUL-2010 to 19-JUL-2011.', 'description': 'The safety population includes all enrolled and dispensed participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Habitual Contact Lens', 'description': "Contact lens per participant's habitual prescription worn for two 30-day periods in Phase 1, with a replacement dispensed at Day 28 in either Period 1 or Period 2.", 'otherNumAtRisk': 78, 'otherNumAffected': 0, 'seriousNumAtRisk': 78, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lotrafilcon B Contact Lens', 'description': 'Contact lens worn for 56 days with a replacement dispensed at Day 28 in Phase 2, followed by 43 days in Phase 3 with a replacement dispensed at Day 1 and Day 14.', 'otherNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Survivors: Lotrafilcon B/Replacement/Replacement', 'description': 'Contact lenses worn for 43 days, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15 during Phase 3. "Survivors" were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2.'}, {'id': 'OG001', 'title': 'Strugglers: Lotrafilcon B/Replacement/Replacement', 'description': 'Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Strugglers" were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'spread': '14', 'groupId': 'OG000'}, {'value': '88', 'spread': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \\& FRESH ("Wow! My eyes feel incredible! I love this feeling.")', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and dispensed participants, Phase 3.'}, {'type': 'PRIMARY', 'title': 'Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Survivors: Lotrafilcon B/Replacement/Replacement', 'description': 'Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Survivors" were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2.'}, {'id': 'OG001', 'title': 'Strugglers: Lotrafilcon B/Replacement/Replacement', 'description': 'Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Strugglers" were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'spread': '19', 'groupId': 'OG000'}, {'value': '76', 'spread': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \\& FRESH ("Wow! My eyes feel incredible! I love this feeling.")', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and dispensed participants, Phase 3.'}, {'type': 'PRIMARY', 'title': 'Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Survivors: Lotrafilcon B/Replacement/Replacement', 'description': 'Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Survivors" were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2.'}, {'id': 'OG001', 'title': 'Strugglers: Lotrafilcon B/Replacement/Replacement', 'description': 'Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Strugglers" were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '21', 'groupId': 'OG000'}, {'value': '67', 'spread': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \\& FRESH ("Wow! My eyes feel incredible! I love this feeling.")', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and dispensed participants, Phase 3.'}, {'type': 'PRIMARY', 'title': 'Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Survivors: Lotrafilcon B/Replacement/Replacement', 'description': 'Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Survivors" were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2.'}, {'id': 'OG001', 'title': 'Strugglers: Lotrafilcon B/Replacement/Replacement', 'description': 'Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Strugglers" were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.of Phase 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'spread': '14', 'groupId': 'OG000'}, {'value': '79', 'spread': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15', 'description': 'Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \\& FRESH ("Wow! My eyes feel incredible! I love this feeling.")', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and dispensed participants, Phase 3.'}, {'type': 'PRIMARY', 'title': 'Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Survivors: Lotrafilcon B/Replacement/Replacement', 'description': 'Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Survivors" were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2.'}, {'id': 'OG001', 'title': 'Strugglers: Lotrafilcon B/Replacement/Replacement', 'description': 'Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Strugglers" were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'spread': '19', 'groupId': 'OG000'}, {'value': '64', 'spread': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15', 'description': 'Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \\& FRESH ("Wow! My eyes feel incredible! I love this feeling.")', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and dispensed participants, Phase 3.'}, {'type': 'PRIMARY', 'title': 'Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Survivors: Lotrafilcon B/Replacement/Replacement', 'description': 'Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Survivors" were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2.'}, {'id': 'OG001', 'title': 'Strugglers: Lotrafilcon B/Replacement/Replacement', 'description': 'Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Strugglers" were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'spread': '21', 'groupId': 'OG000'}, {'value': '60', 'spread': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15', 'description': 'Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \\& FRESH ("Wow! My eyes feel incredible! I love this feeling.")', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and dispensed participants, Phase 3.'}, {'type': 'PRIMARY', 'title': 'Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Survivors: Lotrafilcon B/Replacement/Replacement', 'description': 'Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Survivors" were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2.'}, {'id': 'OG001', 'title': 'Strugglers: Lotrafilcon B/Replacement/Replacement', 'description': 'Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Strugglers" were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'spread': '14', 'groupId': 'OG000'}, {'value': '74', 'spread': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 43', 'description': 'Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \\& FRESH ("Wow! My eyes feel incredible! I love this feeling.")', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and dispensed participants, Phase 3.'}, {'type': 'PRIMARY', 'title': 'Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Survivors: Lotrafilcon B/Replacement/Replacement', 'description': 'Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Survivors" were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2.'}, {'id': 'OG001', 'title': 'Strugglers: Lotrafilcon B/Replacement/Replacement', 'description': 'Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Strugglers" were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'spread': '19', 'groupId': 'OG000'}, {'value': '63', 'spread': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 43', 'description': 'Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \\& FRESH ("Wow! My eyes feel incredible! I love this feeling.")', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and dispensed participants, Phase 3.'}, {'type': 'PRIMARY', 'title': 'Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Survivors: Lotrafilcon B/Replacement/Replacement', 'description': 'Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Survivors" were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2.'}, {'id': 'OG001', 'title': 'Strugglers: Lotrafilcon B/Replacement/Replacement', 'description': 'Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Strugglers" were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '21', 'groupId': 'OG000'}, {'value': '57', 'spread': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 43', 'description': 'Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \\& FRESH ("Wow! My eyes feel incredible! I love this feeling.")', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and dispensed participants, Phase 3.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1: Habitual no Replacement, Then Habitual Replacement', 'description': "Contact lenses per participant's habitual prescription worn for 30 days with no replacement, followed by contact lenses per habitual prescription worn for 30 days with a new pair dispensed at Day 28."}, {'id': 'FG001', 'title': 'Phase 1: Habitual Replacement, Then Habitual no Replacement', 'description': "Contact lenses per participant's habitual prescription worn for 30 days with a new pair dispensed at Day 28, followed by contact lenses per habitual prescription worn for 30 days with no replacement."}, {'id': 'FG002', 'title': 'Phase 2: Lotrafilcon B Replacement', 'description': 'Contact lenses worn for 56 days with replacement pair dispensed at Day 28.'}, {'id': 'FG003', 'title': 'Phase 3: Lotrafilcon B Replacement Replacement', 'description': 'Contact lenses worn for 43 days with replacement pair dispensed on Day 1 and Day 28.'}], 'periods': [{'title': 'Phase 1: Period One, 30 Days of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Inconvenience', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Asymptomatic infiltrates', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Unable to achieve acceptable comfort', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Phase 1: Period Two, 30 Days of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One participant discontinued between Period One and Period Two due to unconvenience.', 'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Inconvenience', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Phase 2: 56 Days of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '67'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '62'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Inconvenience', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Unable to achieve satisfactory comfort', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Phase 3: 43 Days of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from one Canadian research center.', 'preAssignmentDetails': 'Baseline characteristics are presented for all enrolled participants: 78. The participant flow chart includes all enrolled and dispensed participants: 72. Six participants were enrolled but not dispensed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'This reporting group includes all enrolled and dispensed participants.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.7', 'spread': '7.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-26', 'studyFirstSubmitDate': '2010-09-09', 'resultsFirstSubmitDate': '2012-07-26', 'studyFirstSubmitQcDate': '2010-09-09', 'lastUpdatePostDateStruct': {'date': '2012-08-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-26', 'studyFirstPostDateStruct': {'date': '2010-09-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1', 'timeFrame': 'Day 1', 'description': 'Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \\& FRESH ("Wow! My eyes feel incredible! I love this feeling.")'}, {'measure': 'Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10', 'timeFrame': 'Day 1', 'description': 'Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \\& FRESH ("Wow! My eyes feel incredible! I love this feeling.")'}, {'measure': 'Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day', 'timeFrame': 'Day 1', 'description': 'Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \\& FRESH ("Wow! My eyes feel incredible! I love this feeling.")'}, {'measure': 'Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1', 'timeFrame': 'Day 15', 'description': 'Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \\& FRESH ("Wow! My eyes feel incredible! I love this feeling.")'}, {'measure': 'Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10', 'timeFrame': 'Day 15', 'description': 'Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \\& FRESH ("Wow! My eyes feel incredible! I love this feeling.")'}, {'measure': 'Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day', 'timeFrame': 'Day 15', 'description': 'Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \\& FRESH ("Wow! My eyes feel incredible! I love this feeling.")'}, {'measure': 'Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1', 'timeFrame': 'Day 43', 'description': 'Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \\& FRESH ("Wow! My eyes feel incredible! I love this feeling.")'}, {'measure': 'Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10', 'timeFrame': 'Day 43', 'description': 'Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \\& FRESH ("Wow! My eyes feel incredible! I love this feeling.")'}, {'measure': 'Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day', 'timeFrame': 'Day 43', 'description': 'Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \\& FRESH ("Wow! My eyes feel incredible! I love this feeling.")'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Refractive Error']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial was to evaluate the factors affecting comfortable contact lens wear and how those factors affect contact lens replacement frequency.', 'detailedDescription': 'Eligible participants began Phase 1, following either Cycle A or Cycle B, and crossing over to the second cycle after completing the first. After the Phase 1 results were evaluated, eligible participants entered Phase 2. After Phase 2 results were evaluated, participants who consistently reported the highest and the lowest comfort scores entered Phase 3 and were defined as either survivors or strugglers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 17 years of age.\n* Ocular exam in the last two years.\n* Currently wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis with a monthly replacement schedule.\n* Wearing contact lenses at least five days per week for a minimum of 10 hours each day.\n* Able to wear lenses in the available power range with a best-corrected visual acuity of at least 20/32 in both eyes.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Any ocular disease.\n* Systemic condition that may affect a study outcome.\n* Using any systemic or topical medications that may affect ocular health.\n* Wears lenses on an extended or continuous wear schedule.\n* Habitually wears multifocal lenses.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01198600', 'briefTitle': 'Ocular Comfort and the "Aging" Lens (ERBIUM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Ocular Comfort and the "Aging" Lens (ERBIUM)', 'orgStudyIdInfo': {'id': 'P-373-C-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Phase 1: Habitual no Replacement, then Habitual Replacement', 'description': "Contact lenses per participant's habitual prescription worn for 30 days with no replacement, followed by contact lenses per habitual prescription worn for 30 days with a replacement pair dispensed at Day 28.", 'interventionNames': ['Device: Habitual contact lens']}, {'type': 'OTHER', 'label': 'Phase 1: Habitual Replacement, then Habitual no Replacement', 'description': "Contact lenses per participant's habitual prescription worn for 30 days with replacement pair dispensed at Day 28, followed by contact lenses per habitual prescription worn for 30 days with no replacement.", 'interventionNames': ['Device: Habitual contact lens']}, {'type': 'OTHER', 'label': 'Phase 2: Lotrafilcon B Replacement', 'description': 'Contact lenses worn for 56 days with replacement pair dispensed at Day 28.', 'interventionNames': ['Device: Lotrafilcon B contact lens', 'Device: Contact lens cleaning and disinfecting system (ClearCare)']}, {'type': 'OTHER', 'label': 'Phase 3: Lotrafilcon B Replacement Replacement', 'description': 'Contact lenses worn for 43 days with replacement pair dispensed at Day 1 and Day 28.', 'interventionNames': ['Device: Lotrafilcon B contact lens', 'Device: Contact lens cleaning and disinfecting system (ClearCare)']}], 'interventions': [{'name': 'Habitual contact lens', 'type': 'DEVICE', 'description': "Hydrogel or silicone hydrogel contact lens per participant's habitual brand and prescription", 'armGroupLabels': ['Phase 1: Habitual Replacement, then Habitual no Replacement', 'Phase 1: Habitual no Replacement, then Habitual Replacement']}, {'name': 'Lotrafilcon B contact lens', 'type': 'DEVICE', 'otherNames': ['AIR OPTIX AQUA'], 'description': 'Commercially marketed silicone hydrogel contact lens', 'armGroupLabels': ['Phase 2: Lotrafilcon B Replacement', 'Phase 3: Lotrafilcon B Replacement Replacement']}, {'name': 'Contact lens cleaning and disinfecting system (ClearCare)', 'type': 'DEVICE', 'otherNames': ['CLEARCARE'], 'description': 'Commercially marketed, hydrogen peroxide-based contact lens care system', 'armGroupLabels': ['Phase 2: Lotrafilcon B Replacement', 'Phase 3: Lotrafilcon B Replacement Replacement']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2L 3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Waterloo', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}], 'overallOfficials': [{'name': 'Desmond Fonn, MOptom FAAO', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Waterloo Centre for Contact Lens Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CIBA VISION', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Waterloo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}